The document discusses quality assurance and regulatory control in the pharmaceutical industry. It describes key aspects of quality assurance including regulatory drug analysis and interpretation of data. Regulatory authorities like the FDA and DDA in Nepal establish rules and regulations to ensure safety, efficacy and quality of drugs. The FDA oversees drug approval and manufacturing inspections through centers like CDER. It also works with other agencies on issues like advertising claims (FTC), environmental protection (EPA), and workplace safety (OSHA). Similarly, Nepal's DDA regulates drug production, import/export, storage and consumption to implement the objectives of the Drug Act 2035.

1. Quality assurance process
Regulatory Control
Regulatory drug analysis
Interpretation of analytical data

2. Quality ?
 Defect Free
 Customer Satisfaction
 Achieved by Continuous improvement
Quality = Safety  Efficacy  Fit for intended use

3. Quality Assurance
 Wide concept that covers all
aspects that collectively or
individually impact quality of product
 Way of preventing mistakes or
defects in manufacturing product and
avoiding problems when delivering
solutions or services to customers

4. Regulatory Control
• Regulatory = A law or administrative rule ,
issued by an organization , used to guide or
prescribe the conduct of members of that
organization
• Control =Quality decreasing variables are
reduced or eliminated

5. Regulatory Control Where ?
Source (Discovery)
Extraction
Modification
Pre-Clinical Trial
Clinical trial
Approved
Excipients + API
Manufacturing
QC
Packaging
Release
GMP
GLP
ISO
TQM

6. Regulatory Authorities and
Regulatory Control
• Regulatory authorities across the world have
been working their way to develop regulations
which can ensure that only safe and effective
products of high quality and purity reach into
market for commercial distribution .
 US is the developed world where drugs are
most stringently regulated .

7. Regulatory Authorities
International
 USFDA : Based on Federal
Food , Drug and Cosmetic Act
(FDCA)
 Federal Trade
Commission(FTC)
 Environmental Protection
Agency (EPA)
 Occupational safety and
Health Administration (OSHA)
 Drug Enforcement
Administration ( DEA)
Local ( Nepal )
 Department of Drug
Administration (DDA) :
Based on drug act 2035 .

8. 1. FDA
FDA is organized into number of offices and centers
that are assigned with different responsibilities to
accomplish the objective of FDA
1. Center for Drug Evaluation and Research (CDER)
2. Center for Biologics Evaluation and Research(CBER)
3. Center for Devices and Radiological Health (CDRH)
4. Center for Food Safety & Applied Nutrition (CFSAN)
5. Center for Veterinary Medicines (CVM)
These centers are responsible for approving and monitoring of
market drugs /biologics /devices /food/nutraceuticals/cosmetics
and inspecting manufacturing facilities which fall in their respective
authorities .

9. I. Office of Regulatory Affairs (ORA)
 lead office for all regulatory activities as
well as providing FDA leadership on
imports , inspections , and enforcement
policies .
Supports five FDA product centers by
inspecting regulated product and
manufacturers , conducting sample analysis
on regulated products and reviewing
imported products offered for entry in US .

10. ii. Office of Generic Drugs (OGD)
Part of FDA CDER which is dedicated to
approving safe , effective , high-quality and
bioequivalent generic drug products for use by
consumer .
iii. Office of Combination Products (OCP)
Jurisdiction in dispute of combination
Ensure consistency and appropriateness
of post-market regulation of combination
products .

11. iv. Office of Orphan Products (OCP)
Dedicated to promoting the development of products of
rare disease and conditions .
Provides incentives for sponsors and funding for clinical
research .
v. Office of Ombudsman
Address complaints and assists in resolving
disputes between companies or individuals .
Works to resolve externally and internally
generated problems for which there are no legal or
established means of redressing by finding
approaches that are acceptable to both the affected
party and to agency .

12. 2. Federal Trade Commission (FTC)
Prevent false adverting of drugs
Regulates the adverting of OTC drugs,
medical devices and cosmetics .
3. Environmental Protection Agency (EPA)
Regulates pesticide used in agriculture
Ensures that use of pharmaceuticals does not
create unnecessary and excessive hazardous
burdens on the environment such as water air and
land .

13. 4. Occupational Safety and Health
Administration (OSHA)
Regulates the working environment of
employees who may use FDA-regulated
commodities i.e syringes , chemotherapeutics
and chemical reagents .
5. Drug Enforcement Administration (DEA)
Enforces the Federal Controlled Substances Act
(CSA) and is charged with controlling and monitoring
the flow of illicit and licit controlled substances .

14. Local (Nepal )
DDA is establish for the implementation of objective of Drug Act
2035
Preamble
Whereas, it is expedient to prevent the misuse or
abuse of drug and allied pharmaceutical substances
and false or misleading information relating to the
efficacy and use of drugs and to control the
production , sale , export , import , storage and
consumption of drugs which are not safe for public
consumption , efficacious and of standard quality .

15. Chapter-5
Quality Standards of Drugs
12. Drugs to be safe for public consumption , efficacious and of quality standard
13. Prohibition on manufacture ,sale distribution , export , import , storage or
consumption of drugs not conforming to prescribed standard .
14. Return of drugs which is not safe for public consumption efficacious and of quality
standard .
15 . Prohibition of Compensation
16. Submission of letter of guarantee to Department .
17. Categorization of drugs .
18. Prohibition on misuse or abuse of drugs
19. Prohibition on false or misleading advertisement of drugs .

16. Others
28. Prohibition on manufacture , sale , distribution , dispensing
storage without making arrangement of required human
resource
29. Prohibition on adulteration in drugs and sale of adultrated
drugs
30. Prohibition on sale and distribution of date expired drugs
31. License to be obtained from the Department for clinical trial
on new drugs
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17. Drug product in Nepal
Inspection and audit of
manufacturing site
Testing and analysis of Drug
product
Provide import license
Compliance with Drug Manufacturing Code
Audits by DDA
Testing and analysis of Drug product

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